Sovereign Health is a clinical trial management organization in India that provides clinical research services to pharmaceutical, biotech, and medical device companies. It has experience conducting trials across many therapeutic areas in India and aims to generate high-quality, compliant research data. Sovereign Health has an extensive network of over 600 investigators across India and staff to support trials from project management to regulatory services. It works to ensure client satisfaction and quality trial conduct through internal monitoring, training programs, and 24/7 customer support.

1. Sovereign Health
India Pvt. Ltd.
III Floor, SCO-28,
Sector-14, Gurgaon (Haryana)
Tel: +91-124-4166412
Fax: +91-124-4166449
http://www.sovhealthindia.com

2. Introduction
Warm Greetings from Sovereign Health India
Pvt. Ltd!!
Sovereign Health is a Clinical Trial Management
Organization, managing clinical trials in all
therapeutic areas across the globe with compliance
to ICH-GCP providing complete range of clinical
research services to Pharmaceutical, Medical Device,
and Biotechnology companies

3. Sovereign Health – India
Mission:
To conduct studies that conform to the highest level
of quality, compliance, ethical standards and patient
care to generate valid, reliable, credible and quality
research data.

4. ICH-GCP compliant trials
In-depth knowledge of national &
international regulatory issues
Local expertise
Staff training
Centralized systems and infrastructure
Standardized SOPs and QA processes

5. Quality
Sites are judged on the following:
Number of patients recruited
Number of DCFs generated
Adherence to regulatory and protocol
compliance
Standard SOPs
Certified GCP and study specific training
Membership of professional bodies

6. SovHealth Experience
in the conduct of CNS studies
Indication No.of No. of Status
Studies Sites
Alzheimer Disease 02 02 Ongoing, completion Q1-09
09 Enrollment starts Dec 08
Parkinson’s Disease 02 Completed
03 07 Ongoing, completion Q4-08
04 Completed
MDD 01 03 Enrollment starts Nov 08
Schizophrenia 02 03 Completed
05 Completed
Down Syndrome 01 05 Pipeline
Total 09 40

7. Experience in the
conduct of Non CNS studies
Osteo Arthritis 01 06 Pipeline
Rheumatoid Arthritis 01 04 Enrollment Nov’08
Hepatitis 03 10 Enrollment-Dec’08,
2 study-Pipeline
Paediatric Psoriasis 01 03 Pipe Line
Total Hip Replacement 01 06 Q1-09
Medical device 01 02 Q1-09
Allergic Rhinitis 01 05 Feasibility stage
Diabetes 02 11 1 study-Q1-09, 1 pipeline
Oncology 04 20 2 studies-Q4-08,
1 study-Q1-09 & 1 study-pipeline
Gastroenterology 01 05 Q1-09
Gynecology 01 10 Feasibility stage

8. Our Investigator Pool
Sovereign Health has an extensive database of over 600 highly
experienced Investigators from the following therapeutic
areas:
Cardiology (50) Nephrology (26)
Critical care (18) Neurology (45)
Dental (35) Orthopaedics (70)
Dermatology (30) Ophthalmology (30)
Diabetology (45) Oncology (170)
Endocrinology (45) Psychiatry (50)
Gastroenterology (28) Urology (15)
Gynecology (30)
Internal Medicine (30)

9. Investigator Coverage Across
India
North & Central Zone – 250
West Zone – 150
South Zone – 150
East Zone – 50
Most of these investigators hail from Premiere Institutes
of India with a vast patient pool readily available to
participate in clinical studies.

10. Services Offered
Project Management
Clinical Operations
Investigator Services
Regulatory consultancy
Clinical Trial Supply Management
Quality Assurance Services
Medical & research writing

11. Other Services
Training programs and presentations
Corporate compliance program development and
maintenance
FDA/RA inspection preparation
Mock FDA/RA inspections
Facilitation of FDA/RA inspections

12. What makes us different?
Extensive Database of Investigators and
study staff
Providing Centralized Services
Internal Monitoring
Client satisfaction
Regulatory Services
Customer Support

13. What makes us different?
Extensive Database of Investigators and
study staff
Sovereign Health has an extensive database of highly qualified
and experienced Investigators and extensively trained and
experienced CRCs to support the Investigators throughout the
study.
We maintain a healthy and strong association and share an
excellent rapport with the Investigators and the study staff at all
the site. This helps us conducting feasibilities for studies in
various therapeutic areas within a short timeline. We have an
experience of conducting feasibility at 10 sites within a short
span of 1 working day.

14. What makes us different?
Providing Centralized Services
Sovereign Health has dedicated site based personnel,
reporting to Sovereign Health’s Central office with
daily recruitment data, documents data and handling
of logistics at sites. It is often seen that Investigators
have competing priorities and they cannot prioritize
on a Sponsor study, thus our dedicated site based
personnel ensures Sponsor outcomes are met within
timelines.

15. What Makes us different?
We ensure that all our site based personnel are well versed with
the SOPs and ICH GCP and other regulatory guidelines before
being placed at the respective sites. We recruit local personnel
as CRCs who have a command with the local dialect to minimize
the difficulty of communication with the patient population.
Sovereign Health provides online training and certification to the
Investigators not only towards the ongoing studies but also in
general to the various other clients and students.

16. What Makes us different?
Our CRCs are highly efficient to manage huge patient population
in hospitals having huge OPD crowd. They are also trained to
manage patients with the utmost hospitality and care in
situations of long OPD hours and / or circumstances such as
longer hours of procedure during screening and also sometimes
during the study.

17. What Makes us different?
Internal Monitoring
The fact that we conduct internal monitoring visits at our sites
prior to the RMV (Regular Monitoring Visit) done by Sponsor /
CRO representatives, makes SH a unique SMO.
Our monitors (Project Associates) visit every site as and when
required to monitor the TMF (study file) to check the availability
of all the documents as per the Regular Monitoring Visit
checklist and also ensure that all the previous issues with Data
Clarification Forms have been resolved. This activity of our SMO
saves time and effort of the Sponsor / CRO personnel and also
helps the study conduct with minimum DCFs being generated.

18. What Makes us different?
Client satisfaction
Sovereign Health maintains a very healthy relation with the
clients (Sponsors and CROs) by delivering a timely and quality
data from the sites. This is how we are favored by our clients
and being awarded with repeated number of studies.
Our Investigators are well recognized in the Clinical Research
and pharmaceutical Industry and have also been awarded for
their valuable contribution towards the drug development
process.

19. What Makes us different?
Client satisfaction
This is the reason behind the massive expansion of SovHealth’s
therapeutic area of expertise from CNS to a domain of varied
therapeutic areas such as Gynecology, Urology, Hepatoogy,
Gastroenterology, Oncology, Dermatology, Orthopedics etc
within a short span time.

20. What Makes us different?
Regulatory Services
SHIPL also renders the services of regulatory submission and
timely approval to the Sponsor with minimal hassle.
Customer Support
We offer 24 X 7 round the clock support service to all our sites
and clients.

21. Success of Clinical Trials depends on
Good information flow
Open communication
Channels among participants

22. Contact Us
For all business related queries please contact
Mr. Suraj Shaw
(Business Development Executive-Clinical Research)
at
s.shaw@sovhealth.com or +91-9311423408

23. Sovereign Health
A partner in your study success
Thanks !
www.sovhealthindia.com